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Clinical trials explained

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Thousands of new clinical trials are registered every year globally, each playing a pivotal role in the validation of new therapies and medical interventions.

Importantly, clinical trials aren’t just a regulatory requirement but a critical phase in the lifecycle of drug development, offering tangible insights into the efficacy and safety of prospective treatments.

This article aims to demystify the process and significance of clinical trials, shedding light on their role as an essential conduit for therapeutic innovation and market readiness.

What is a clinical trial?

Clinical trials are research studies that aim to evaluate a medical, surgical, or behavioural intervention. Performed in humans, they are the primary way researchers discover whether new treatments are safe and effective.

Clinical trials play a crucial role in advancing medical knowledge and patient care, serving as a bridge from laboratory research to bringing new treatments to the market and into the hands of patients.

Why are clinical trials important?

Clinical trials are vital for developing new treatments for diseases and improving current treatments. By participating in clinical trials, volunteers can play a key role in helping to:

  • discover new treatments for chronic conditions
  • improve the standard of care for diseases
  • ensure the safety and efficacy of new medications

Trials can create new possibilities in healthcare, offering hope for many diseases with limited treatment options.

Global clinical trial landscape

The global landscape of clinical trials is vast and varied, reflecting the worldwide effort to advance medical research.

  • North America and Europe lead in the number of clinical trials conducted, with significant growth observed in Asia-Pacific regions.
  • Conditions such as cancer, cardiovascular diseases, and infectious diseases typically represent the highest number of trials.

This global effort underscores the collaborative nature of advancing healthcare and treatments across borders.

Understanding clinical trial phases

Clinical trials are conducted in phases, each with a different purpose:

  • Phase I: Tests the safety of a new treatment in a small group of people.
  • Phase II: Explores the efficacy of the treatment in a larger group.
  • Phase III: Confirms effectiveness, monitors side effects, and compares it to commonly used treatments.
  • Phase IV: Occurs after approval by the relevant authority to gather more information on the treatment’s long-term risks and benefits.

Each phase is crucial to the meticulous process of bringing a safe and effective new treatment to the public.

The future of clinical trials

The landscape of clinical trials is evolving with technology and patient needs at the forefront:

  • Digital technology: Wearables and mobile apps are being used for real-time data collection and patient monitoring.
  • Decentralised trials: Trials are increasingly being conducted remotely, reducing the need for participants to travel to study sites.
  • Patient-centric approaches: There’s a growing focus on making trials more accessible and less burdensome for participants.
  • Precision medicine: Tailoring treatments based on genetic, environmental, and lifestyle factors is becoming more common.

These trends are revolutionising how clinical trials are conducted, making them more efficient, inclusive, and patient-focused. Learn more about the external market factors shaping clinical trials.


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Image by ThisisEngineering RAEng on Unsplash.

INSIGHT

AUTHOR

George Vlachos
Director